Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526214
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2007-09-06
Brief Title:
Administration of Celecoxib for Treatment of Intracerebral Hemorrhage A Pilot Study
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Multi-center Prospective Randomized Comparative Open With Blinded Endpoints PROBE Trial to Assess the Safety and Effectiveness of Administration of Celecoxib in Patients With Intracerebral Hemorrhage
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACE-ICH
Brief Summary:
Primary
Change of volume of perihematomal edema as assessed by brain CT
Secondary
The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study
Change of volume of perihematomal edema as assessed by brain CT
Secondary
The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study
Detailed Description:
1 INCLUSIONEXCLUSION CRITERIA
1 Inclusion Criteria
Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
Supratentorial location of hemorrhage
Older than 17 yrs
Informed consent before study
2 Exclusion Criteria
Planned surgical evacuation of hematoma within 24hrs
Secondary ICH such as trauma or aneurysmal rupture
Taking anticoagulation previously
Pregnancyknown allergy to celecoxib severe liver or kidney disease or poor performance state were excluded
Other physical condition making the patient difficult to participate in this study decided by the neurologist or the physician
2 OTHER THERAPY
-No limitation of other medications except NSAIDs anticoagulation and antiplatelet agent because of aggravating the symptoms
3 STUDY DESIGN Multicenter prospective randomized comparative open with blinded endpoints PROBE trial to assess the safety and effectiveness of administration of celecoxib for 14 days in patients with intracerebral hemorrhage
1 Inclusion Criteria
Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
Supratentorial location of hemorrhage
Older than 17 yrs
Informed consent before study
2 Exclusion Criteria
Planned surgical evacuation of hematoma within 24hrs
Secondary ICH such as trauma or aneurysmal rupture
Taking anticoagulation previously
Pregnancyknown allergy to celecoxib severe liver or kidney disease or poor performance state were excluded
Other physical condition making the patient difficult to participate in this study decided by the neurologist or the physician
2 OTHER THERAPY
-No limitation of other medications except NSAIDs anticoagulation and antiplatelet agent because of aggravating the symptoms
3 STUDY DESIGN Multicenter prospective randomized comparative open with blinded endpoints PROBE trial to assess the safety and effectiveness of administration of celecoxib for 14 days in patients with intracerebral hemorrhage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-2007-0084 | None | None | None |